September 10, Dear Valued Customer:

Transcription

1 September 10, 2012 Subject: Change in design and material of protective cap component and product packaging for Lynx S2S connector. Effective date January 1 st, Recommended Action: None Information Only Reference No.: KCN-72E16A831ESS Dear Valued Customer: This is to inform you that is making changes to enhance the performance and packaging of the Lynx S2S connector. The figures and tables attached to this letter outline the details of the changes and the catalogue numbers affected. These changes are in non-fluid contact components and are summarized below: Protective Cap (see figure 1): o Material of construction will change from a thermoplastic elastomer to polysulfone. o Design change to enhance autoclave robustness and ease of cap removal. Packaging Change (see figure 2, 3 and 4): o Easy tear off feature added to the outer packaging bag to the Lynx S2S male and female connector. o Smaller outer cardboard box with inner bulk polyethylene plastic liner for all 24-pack Male and Female Lynx S2S catalogue numbers. Our records indicate that your company has purchased one or more of these affected products within the past two years. strives to provide you with the highest quality products and attempts to make changes with as little disruption to your process as possible. Therefore, a copy of this notification should be forwarded immediately to the personnel in your organization affected by this change. Starting January 1 st, 2013, you may begin to receive Lynx S2S products utilizing the new design and material of the protective cap and new packaging. The above changes will be qualified using our established change control procedure and qualification summary report will be available in October 2012 for your review upon request. If you would like more information about this change notification, please contact your local representative or Technical Service. Outside the U.S., see your catalog for the phone number of the office nearest you or go to our web site at for up-to-date worldwide contact information. You can also visit our web site at or the technical service page at

2 Thank you for your loyal business with. Sincerely, Stephen Mickle Supplier Quality Engineering Manager Supply Chain Finished Goods Ernest Jenness Mobius, Product Manager Process Solutions Attachment

3 Figure 1: Lynx S2S Connector Fitting, Current and New Protective Cap Figure 2: EZ Open Feature for Outer Polyethylene Bag EZ open feature shown in lower left of the bag (bag partially opened for viewing)

4 Figure 3: Current Outer Box (bottom) and New Smaller Box (top) Figure 4: Inner Bulk Bag for 24 pack Lynx S2S Male and Female Connectors

5 Table 1: Affected Lynx S2S Product Catalogue Numbers Lynx S2S Part Description Number SSCSHB1A01 Lynx S2S Connector, ¼ Hose Barb, 1 Female and 1 Male SSCSHB2A01 Lynx S2S Connector, ½ Hose Barb, 1 Female and 1 Male SSCSHB3A01 Lynx S2S Connector, ⅜ Hose Barb, 1 Female and 1 Male SSCFHB1A24 Lynx S2S Connector, ¼ Hose Barb, 24 Female Connectors SSCFHB2A24 Lynx S2S Connector, ½ Hose Barb, 24 Female Connectors SSCFHB3A24 Lynx S2S Connector, ⅜ Hose Barb, 24 Female Connectors SSCMHB1A24 Lynx S2S Connector, ¼ Hose Barb, 24 Male Connectors SSCMHB2A24 Lynx S2S Connector, ½ Hose Barb, 24 Male Connectors SSCMHB3A24 Lynx S2S Connector, ⅜ Hose Barb, 24 Male Connectors Table 2: Summary of Changes Change description PROTECTIVE CAP Raw Material change from Thermoplastic Elastomer to Polysulfone. The new protective cap is molded with the same grade of Polysulfone plastic used for all the other Lynx S2S connector components. Design change to enhance autoclave robustness and ease of cap removal. PACKAGING Easy tear off feature added to the outer packaging bag of the Lynx S2S male and female connectors. Smaller outer cardboard box with inner bulk polyethylene plastics liner for all 24 pack Male and Female Lynx S2S Catalogue numbers. Reason for change Expected impact and/or consequences of change Date of final change Identification of product made with new material Product improvement. The actuation steps per the User Guide have not changed. The changes to all the Lynx S2S products will be implemented at our current manufacturer by Dec 31 st, You may start receiving your order with these changes starting January 1 st, has the ability to trace these changes based on lot number.

6 The Lynx S2S catalogue numbers are not changing. Changes to release testing procedures, specifications or validation Changes in animal origin status Changes to shelf life Changes to Certificate of Quality or labeling Changes in packaging, shipping, or storage Smaller outer box for the 24 packs with reduced corrugated and the addition of a polyethylene bulk bag. Individual devices will have an EZ open outer bag.